October 3, 2024 -- InvestorsHub NewsWire --
via NetworkNewsWire
Editorial Coverage: Pharmaceutical companies are demonstrating
innovation by not only developing new drugs but also exploring
combination therapies and repurposing existing drugs to address
unmet medical needs. This strategic approach holds promise for
providing hope to millions of patients suffering from historically
challenging diseases. Alzheimer's disease ("AD") for example, has
become a focal point of this innovation, with recent U.S. Food and
Drug Administration ("FDA") approvals of Leqembi and Kisunla —
although these treatments only slow cognitive decline rather than
improve cognitive function. New uses for approved glucagon-like
peptide-1 ("GLP-1") and phosphodiesterase 5 ("PDE5") inhibitor
drugs show promise in treating Alzheimer's, with companies such
as Annovis Bio Inc. (NYSE:
ANVS) (profile) leading the way with treatments
ready for late-stage clinical trials. Beyond Alzheimer's, the
pharmaceutical industry is experiencing a surge of innovation
across various disease areas. Major players,
including Johnson & Johnson (NYSE:
JNJ), Novartis (NYSE:
NVS), Merck & Co. Inc. (NYSE:
MRK) and GSK
plc (NYSE: GSK) are at the
forefront of medical innovation, tackling previously intractable
diseases.
- Annovis is leading the way in the
development of buntanetap, currently testing the drug in pivotal
clinical trials for Alzheimer's and Parkinson's diseases.
- The company has secured intellectual
property for innovative combination therapies involving buntanetap
and other drugs, including Trulicity(R) and Viagra(R), which work
together to enhance cognitive function.
- Annovis' planned phase 3 studies may
evaluate both double combinations (buntanetap with GLP-1 agonist or
PDE5 inhibitor) and a triple combination of all three drugs.
Click here to view the custom infographic of
the Annovis Bio editorial.
Buntanetap Targeting Alzheimer's Disease
Annovis Bio Inc. (NYSE: ANVS) is
leading efforts to develop innovative and safe treatments for
neurodegenerative diseases such as Alzheimer's. The company's main
focus is enhancing nerve cell health to improve cognition in such
conditions, a target that has proved elusive for peers. The
company's flagship drug candidate, buntanetap, has completed
advanced-stage clinical trials for both AD and Parkinson's disease
("PD") and has shown compelling results in both indications.
Earlier in the year, Annovis shared positive data from a phase
2/3 trial evaluating buntanetap as an oral therapy for early-stage
AD. This trial, which included 353 participants, assessed both the
drug's effectiveness alongside standard care, as well as providing
insight on the safety profile. The results demonstrated cognitive
improvements across all doses compared to placebo, with the 30mg
dose showing the greatest benefit, measured by the ADAS-Cog 11
scale. These findings aligned with prior studies (NCT04524351, NCT02925650), with buntanetap also reducing key
disease biomarkers including neurofilament light ("NFL"), tau
protein and the inflammatory biomarker glial fibrillary acidic
protein ("GFAP"). Annovis is currently planning for a confirmatory
phase 3 trial in biomarker-positive early AD patients to support an
anticipated New Drug Application ("NDA") submission.
Recently, Annovis expanded its approach by exploring
combinations of buntanetap with drugs such as Trulicity
(dulaglutide) and Viagra (sildenafil), either as individual
combination therapies or a three-prong approach utilizing all for
their unique strengths. The three drugs bring their own strengths
to the combination table. Trulicity, a popular GLP-1 agonist, has
been shown to improve brain glucose metabolism. Viagra is known to
enhance cerebral blood flow. Buntanetap inhibits the production of
neurotoxic proteins, including amyloid beta, tau, alpha-synuclein
and TDP-43, and improves the flow of information, offering a
potential to restore cognitive function in patients.
Next-Generation AD Opportunity
Annovis recently unveiled preclinical
data demonstrating that combining buntanetap with
Trulicity in an Alzheimer's mouse model yielded synergistic
benefits. While both drugs individually improved cognitive
function, their combined impact surpassed that of healthy controls
by 16%, reinforcing the potential of combination therapies for AD
treatment.
It is theorized that the improvement as a combination is
undergirded by the neurotoxic inhibiting attributes of buntanetap
paired with Trulicity's ability to penetrate the blood-brain
barrier and normalize glucose metabolism. This groundbreaking
research marks the first instance of a treatment restoring
cognitive function beyond normal levels.
"We are excited to see that buntanetap significantly amplifies
the effects of dulaglutide on memory and learning, with a 6- to
10-fold increase in efficacy," said Annovis Bio founder, president
and CEO Maria Maccecchini, PhD, regarding the study results.
A Fresh Perspective on an Old Problem
The fight against neurodegenerative disease potentially could
get a boost from unexpected sources, as drugs traditionally used
for diabetes and erectile dysfunction ("ED") are used for AD.
GLP-1 Agonists
Originally designed to treat type 2 diabetes, these drugs (such
as semaglutide and liraglutide) mimic a hormone that regulates
blood sugar. While helping diabetics control glucose, researchers
noticed an additional benefit: significant weight loss. This led to
the approval of drugs such as Wegovy for obesity treatment that act
by suppressing appetite and increasing fat burning.
The benefits do not stop there. Recent studies suggest GLP-1
drugs may also reduce the risk of heart disease, kidney disease and
stroke, and even possibly protect the brain from AD by reducing
inflammation, improving brain's insulin sensitivity and enhancing
neuroplasticity (the brain's ability to form new connections).
Early clinical trials are promising. Mid-stage
data showed Liraglutide (Victoza), a GLP-1 drug, to
significantly minimized brain shrinkage in memory, learning and
language areas compared to a placebo.
PDE5 Inhibitors
These medications (such as Viagra and Cialis), known for
treating ED where smooth muscle contraction is paramount, are also
being explored for AD. Although commonly used for their blood
pressure-lowering effects, preclinical studies suggest they
can improve synaptic
function (communication between brain cells) and cerebral
blood flow while also enhancing cognitive abilities. Currently,
four oral PDE5 inhibitors are available in the United States:
sildenafil (Viagra(R), Pfizer), vardenafil (Levitra/Staxyn(R),
Bayer), tadalafil (Cialis(R), Eli Lilly), and avanafil (Stendra(R),
Vivus).
Real-world data also paints a hopeful picture. Notably,
sildenafil (Viagra) is linked to a reduced risk of dementia in
patients who take it. Cleveland
Clinic-led research discovered that in Alzheimer's
patients, sildenafil reduces levels of neurotoxic tau proteins,
known contributors to the disease. Additionally, neurons treated
with sildenafil exhibited enhanced cell growth, improved brain
function and reduced inflammation, all of which are crucial for
protecting against the neural degeneration associated with
Alzheimer's.
This promising research suggests both GLP-1 agonists and PDE5
inhibitors could have a neuroprotective effect, offering a new
approach to combatting AD. By targeting the disease from multiple
angles, these drugs hold potential for a more holistic treatment
strategy.
Growing Patent Estate
Annovis has taken a proactive step to protect its intellectual
property by filing three
new patents for innovative combination therapies involving
buntanetap. These patents encompass combinations with Trulicity and
Viagra, as well as a synergistic approach using all three drugs.
The combination of these drugs provides a competitive advantage to
Annovis insomuch that buntanetap has completed phase 3 studies as a
standalone treatment and the others are already FDA approved. To
wit, Annovis is well positioned to initiate phase 3 clinical
studies.
Further, this multifaceted approach offers unprecedented
potential in combating neurodegeneration, especially considering
the growing prevalence of AD in the U.S. Neurodegenerative diseases
are on the rise, with Alzheimer's affecting nearly 6.7 million
Americans today. Without significant medical breakthroughs, this
number is projected to double to 13.8 million by 2060. With
buntanetap already completing phase 3 trials and Trulicity and
Viagra being FDA approved, these combination therapies are well
positioned for further clinical development under the protection of
Annovis' patents.
Other Innovators
A wave of innovative treatments is emerging, offering hope for
patients with previously challenging conditions. The outlook is
brightening as promising therapies are being developed, paving the
way for a brighter future in healthcare.
Johnson & Johnson (NYSE:
JNJ), a multinational pharmaceutical, biotechnology,
and medical technologies corporation, is focused on healthcare
innovation that builds a world where complex diseases are
prevented, treated and cured; and where treatments are smarter and
less invasive; and solutions are personal. Most recently the
company invested
more than $2 billion in new, advanced technology
manufacturing facility in North Carolina to support robust
portfolio growth. The new facility will expand production
of Johnson & Johnson's innovative biologic medicines in
areas including oncology, immunology, and neuroscience;
construction on the state-of-the-art structure is slated to begin
in the first half of 2025.
Novartis (NYSE:
NVS) is an innovative medicines company with
research and development at its core. The company's
R&D engine powers an industry-leading pipeline that is
focused on delivering transformative medicines to fight disease,
restore possibility and help people live life on their own terms.
The company's researchers work across several diseases areas to
drive drug discovery and early development, while its development
organization leads the advanced clinical development of those
medicines. This work is powered by technology platforms that help
the company innovate across its core therapeutic areas:
cardiovascular, renal and metabolic, oncology, immunology and
neuroscience.
Merck & Co. Inc. (NYSE:
MRK) is developing an investigational
GLP-1/glucagon receptor co-agonist: efinopegdutide (MK-6024). The
experimental drug efinopegdutide, which is being developed as a
treatment for nonalcoholic steatohepatitis ("NASH") and was granted
Fast Track Designation by the U.S. Food and Drug Administration
("FDA") for this treatment, also showed a weight-loss
benefit, said CEO
Robert Davis during the 45th Annual Goldman Sachs
Healthcare Conference.
GSK
plc (NYSE: GSK) was at this year's Alzheimer's
Association International Conference, presenting four new abstracts
contributing to early science in neurodegenerative diseases. More
specifically, GSK was presenting results from the ZOSTER-122
retrospective, observational matched-cohort study in adults aged 50
years and over, which examines the potential association between
Shingrix (Recombinant Zoster Vaccine or RZV) vaccination and
reduced risk of dementia compared to two other vaccines.
These pharmaceutical players are working to find effective
treatments for diseases that for decades have been underserved.
Potential breakthroughs in the development of new drugs could mean
big success for these companies and, even more important,
significant benefits for the individuals suffering from these
diseases.
For more information about Annovis Bio Inc. (NYSE:
ANVS), please visit Annovis Bio
Inc.
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